A MHealth Intervention to Improve Symptom Control in Children and Adolescents with Difficult-to-control Asthma

NCT04166344 | Completed DMC

• 1 other identifier: LVX-ASTHMA-2019
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

Asthma is the most common chronic respiratory disease worldwide. Despite advances in asthma management, control of the disease is still a challenge especially among children. Information and communications technology (ICT) have been recently used in clinical practice to increase awareness of diseases, encourage patients to engage in the management of their conditions and improve monitoring and surveillance. The investigators of this study will test a new digital platform combining online/offline content aimed to improve asthma control and reduce exacerbations and unnecessary consultations in children with difficult-to-control asthma. A randomised controlled trial enrolling 60 patients allocated in two groups has been designed. The intervention group (IG) will be granted free access during 6 months to a web-based platform. During this period, patient will have access to online/off line content to improve disease awareness, monitor signs and symptoms and will also get the support of a respiratory coach. In addition, patients in this group will receive an electronic peak flow meter to register daily variations in maximal expiratory flow and an electronic device to connect to their inhaler to track adequate intake of inhaled medication. The control group (CG) will receive usual care consisted of scheduled visitations to medical doctors every 4 - 8 weeks. Both groups will be evaluated at baseline, post-intervention (6 months) and at follow up (one year) in the following variables: age, gender, asthma severity classification according to international guidelines, date of diagnosis, weight, height, Body Mass Index (BMI), forced expiratory volume in 1 second (FEV1), Asthma Control Test (ACT) score, treatment received for asthma, number of exacerbations in the previous 6 months and concomitant diseases. Exacerbations will be defined as any worsening in asthma symptoms that requires an increase in the usual therapy, an unscheduled physician visit, treatment in the emergency room or hospitalization.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (2)

• Differences in asthma control inter-group

  Differences in asthma control (score) will be calculated according to the Asthma Control Test (ACT) in comparison with the control group. The ACT consists of five items that are rated according to a five-point scale where where 1 means poor control and 5 indicates better asthma control.

  6 months

• Differences in asthma control inter-group

  Differences in asthma control (score) will be calculated according to the Asthma Control Test (ACT) in comparison with the control group. The ACT consists of five items that are rated according to a five-point scale where where 1 means poor control and 5 indicates better asthma control.

  12 months

Secondary Outcomes (7)

• Inclusion rates (feasibility)

  Baseline

• Completion rates

  12 months

• Incidence of exacerbations

  12 months

• Changes in lung function (FEV1)

  6 Months

• Changes in lung function (FEV1)

  12 Months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the IG will be given free access to the HappyAir platform during a 6-month period. This platform combines online/offline content to help patients with chronic respiratory diseases monitor their symptoms and improve self-management. In addition to tailored information on their condition, participants will be encouraged to fill in daily data on their physical activity levels, symptomatology, use of rescue medication and mood. In children under 12 years, parents or caregivers will fill in this information. Patients will be asked to record their peak expiratory flow using an electronic peak flow meter twice daily. Every patient will be assigned a respiratory coach who will monitor patient during the study and whom the patients can contact at any time.

Behavioral: Happyair Ecosystem

Control Group

NO INTERVENTION

Subjects in the CG will receive standard care consisting of periodic visitations at the Allergology or Paediatric Pulmonology Unit in their respective hospitals every 4 - 8 weeks according to their physician's criteria. In addition, patients and caregivers in both groups will receive one educational session regarding the correct use of their inhalers.

Interventions

Happyair Ecosystem BEHAVIORAL

Happyair Ecosystem is a Smart Community for the integral care of patients with chronic or rare respiratory diseases such as Asthma, COPD or Alfa-1. Our community provides online \& offline training and resources in digital health and social care to patients, family, caregivers, healthcare professionals and researchers. Using our platform, all of our members will be able to connect in order to improve the health and well-being of patients, learn to manage self-care, ensure an active lifestyle, and contribute to the development of current and future research projects.

Intervention Group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• children between 6 and 18 years old;
• diagnosis of moderate to severe persistent asthma according to the international guidelines
• difficult to control asthma according to a scoring in the Asthma Control Questionnaire (ACQ) of 1.5 points or Asthma Control Test (ACT) ≤19;
• access to internet and a smartphone, tablet or computer;
• ability to understand and use the web-based platform (in children \<12 years the ability of the tutor or legal guardian);
• informed consent (by the tutor or legal guardian)

You may not qualify if:

• patients who have had an exacerbation in the previous two weeks;
• patients with intermittent asthma and/or well-controlled asthma according to the Asthma Control Questionnaire (ACQ) score of \<1.5 or Asthma Control Test (ACT) score ≥20;
• any neurological or psychiatric condition that prevents patients to use adequately the platform.

Sponsors & Collaborators

• Lovexair Foundation: lead
• Hospital Vall d'Hebron: collaborator
• Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau: collaborator
• Hospital Universitari Parc Salut Mar: collaborator
• Corporacion Parc Tauli: collaborator

Study Sites (4)

Hospital del Mar

Barcelona, Barcelona, 08003, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, Barcelona, 08035, Spain

Location

Hospital Santa Creu i Sant Pau

Barcelona, Barcelona, 08041, Spain

Location

Hospital Universitari Parc Taulí

Sabadell, Barcelona, 08208, Spain

Location

Related Publications (13)

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  PMID: 20530041 BACKGROUND

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  PMID: 19014848 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The statistical analyses will be performed by one researcher unaware of patient allocation
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: November 13, 2019
• First Posted: November 18, 2019
• Study Start: September 1, 2021
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2024
• Last Updated: October 31, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)